A Phase 1, Single-Center, Open-label Study to Evaluate the Safety and Pharmacokinetics of Two Tablet Formulations of PRN1008

Phase 1

Completed

• Conditions: Pemphigus Vulgaris; Rheumatoid Arthritis; Skin - Dermatological conditions; Inflammatory and Immune System - Rheumatoid arthritis

• Registration Number: ACTRN12616001557426
• Lead Sponsor: Principia Biopharma Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Healthy adult male or non-pregnant, non-lactating females, 18 to 65 years of age (inclusive) at the time of screening
- Body mass index (BMI) greater than or equal to 18 (kg/m2) (inclusive), and less than or equal to 35 (kg/m2) (inclusive), and a minimum body weight of 45 kg
- Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study
- A female subject of childbearing potential with a negative pregnancy test agrees to abstinence or use of condoms plus one other acceptable form of contraception; i.e. intrauterine device, hormonal contraception, or a female diaphragm, until 4 weeks after dosing with study drug – OR – has only same-sex partners, when this is her preferred and usual lifestyle
- Male subjects with female partners of childbearing potential must agree to use condoms for the duration of the study and until 12 weeks after dosing with the study drug
- Negative urine drug/alcohol testing at screening and check-in (Day -1). Screening urine drug/alcohol testing may be repeated once if deemed appropriate by the site Investigator
- Willing to abstain from consuming grapefruit- or Seville orange-containing products from 14 days prior to first dose of study medication through follow-up

Exclusion Criteria

- Use of any prescription or over-the-counter (OTC) medication, including herbal products and supplements, within the 14 days or 5 half-lives prior to Day 1 (whichever is longer). Use of less than or equal to 2g paracetamol per day is allowed prior to and during the study.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C antibodies (HCV)
- Use of more than two tobacco/nicotine-containing products per month within 6 months prior to the first study drug administration
- History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration.
- Regular alcohol consumption of greater than 14 units per week (1 unit = 1/2 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- History of any significant (as determined by the Investigator) drug-related allergic reactions such as, anaphylaxis, Stevens-Johnson syndrome, urticarial or multiple drug allergies
- Blood donation or significant blood loss within 30 days prior to screening
- Plasma donation within 14 days prior to the first study drug administration
- Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 30 days prior to the first study drug administration or 5 half-lives, whichever is longer
- surgery within the past three months prior to the first study drug administration determined by the PI to be clinically relevant
- Personal or family history of prolonged QT syndrome or family history of sudden death
- QTcF greater than 450 msec (males) or greater than 470 msec (females) or less than 300 msec at screening,or prior to dosing, unless deemed clinically insignificant by the Investigator
- Screening ECG with QRS and/or T-wave judged to be unfavorable for a consistently accurate QT measurement as judged by the Investigator
- Evidence of atrial fibrillation, atrial flutter, complete bundle branch or heart block, Wolff-Parkinson-White Syndrome, or cardiac pacemaker at screening or prior to dosing
- Semi-supine resting systolic blood pressure (SBP) greater than 150 or less than 90 mm Hg, or diastolic blood pressure greater than 95 or less than 50 mm Hg
- Resting HR less than 45 bpm or greater than 90 bpm at screening or prior to dosing.
- Hypersensitivity or history of idiosyncratic reaction to any components or excipients of the investigational formulation
- Active infection
- Participant is febrile, temperature greater than 37.5 degrees C assessed at screening or prior to dosing
- Any acute illness within 30 days prior to Day 1 unless deemed clinically insignificant by the Investigator and discussed with the Sponsor.
- History of seizure within the past 5 years, whether epileptic, paroxysmal, or of unknown origin
- Failure to satisfy the Investigator of fitness to participate for any other reason
- History or presence of any other medical condition that makes the participant unsuitable for the study in the opinion of the Investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified